FMEA Requirements in QS-9000's TE Supplement

[Zanzi]

FMEA's

Please help if you can - I am confusing myself more and more every day!

What is the requirement for FMEA's in QS9000 TE??? We design and manufacture one off automatic gauging equipment and I believe the requirements to be as follow:

Design FMEA - review the ability of our design to met the design input requirements (design verification) / design intent

Process FMEA - a review of our manufacturing processes e.g. failures in our machine shop, assembly failures etc (are these the internal process that should be addressed by this discipline)

Do we require machinery FMEA's????

You help is most appreciated - I can't be anymore confused!! Any suggestions on how we can fulfill these requirements really is appreciated.

 

[matthew evans - 2002]

Reading the requirements for FMEA (4.2.3.5) in the TE suppliment it does not state that you stop using Process FMEA's.

IMHO machinery FMEA's are the way to go. If you have a copy of Ford's guidelines on FMEA analysis it defines a machinery FMEA as:

"a standardized technique for evaluating equipment and tooling during it's design phase to improve the operator safety, reliability and robustness of the machinery".

Sounds applicable to TE suppliers to me!